BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 3103466 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01577
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RECEIVED AND EVALUATED. ENGINEERING CONFIRMED THAT THE BLACK MAIN TUBE INSULATION WAS DAMAGED AT THE DISTAL END. THE INSULATION WAS GOUGED ON ONE SIDE AND HAD A 0.050 X 0.050 PIECE MISSING ROUGHLY 0.800 ABOVE THE INSTRUMENT'S SNAKE WRIST. THE DISTAL END ALSO EXHIBITED VARIOUS SCRATCH MARKS WITHOUT MATERIAL REMOVAL. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING CENTRAL PROCESSING, THE USER FACILITY IDENTIFIED A HOLE IN THE INSULATION OF THE THORACIC GRASPER INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT. THE INSTRUMENT REPORTEDLY WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203504 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10111222 748

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES